Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment

NCT00548197 — Phase 1, Completed, 40 participants, Iran University of Medical Sciences

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Registry	NCT00548197
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	40 (Actual)
Sponsor	Iran University of Medical Sciences (Other)
Conditions	Intravitreal Bevacizumab Injection, Pars Plana Vitrectomy, Tractional Retinal Detachment, Diabetic Retinopathy
Interventions	Bevacizumab (Drug)
Dates	start 2007-02-01, primary completion 2008-02-01, completion 2008-03-01, first posted 2007-10-23, last updated 2018-10-16
Locations	1 site in Iran

-Summary

Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used.

Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery..

In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation.

During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.

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+Detailed description

Eligibility criteria:

Diabetic tractional retinal detachment-complexity score between 4 and 8

Main outcome measures:

best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)

+Arms and interventions

Arm	Type	Interventions	Description
Intervention group	Experimental	Drug: Bevacizumab	Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy
Control group	No intervention		no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy

Bevacizumab (Drug), also known as Brand name of Bevacizumab is Avastin: one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy

+Outcome measures

Primary outcomes

Best Corrected Visual Acuity [last follow up, an average of 7 months post-operation]: Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)

Secondary outcomes

Anatomic Status of the Retina [Last follow up, an average of 7 months post-operation]: Number of Participants with Postoperative Vitreous Hemorrhage

+Eligibility

Sex: All, ages: 18 Years to 90 Years

Inclusion Criteria:

* Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy.
* Complexity score between 4 and 8.

Exclusion Criteria:

* Previous vitreoretinal surgery.
* Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.

+Posted results

Participant flow

Milestone	Control Group	Intervention Group
Started	18	22
Completed	18	22
Not completed	0	0

Outcome results

Best Corrected Visual Acuity (Primary), Mean, LogMar: Intervention 1.1 +/- 0.4; Control 1.4 +/- 0.3
Anatomic Status of the Retina (Secondary), Count of participants, Participants: Intervention Group 0; Control Group 7

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Intervention	0/22 (0.0%)	1/22 (4.5%)	0/22 (0.0%)
Control	0/18 (0.0%)	1/18 (5.6%)	0/18 (0.0%)

Serious adverse events by term

Term	Organ system	Intervention	Control
Inferior rhegmatogenous retinal detachment and perisillicone proliferations	Eye disorders	1/22	1/18

+Locations (1)

Facility	City	Country	Status
Rasool Akram Hospital	Tehran	Iran

+Publications

Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. doi: 10.1097/00006982-200603000-00004. PMID 16508426
Castellarin A, Grigorian R, Bhagat N, Del Priore L, Zarbin MA. Vitrectomy with silicone oil infusion in severe diabetic retinopathy. Br J Ophthalmol. 2003 Mar;87(3):318-21. doi: 10.1136/bjo.87.3.318. PMID 12598446
Grisanti S, Biester S, Peters S, Tatar O, Ziemssen F, Bartz-Schmidt KU; Tuebingen Bevacizumab Study Group. Intracameral bevacizumab for iris rubeosis. Am J Ophthalmol. 2006 Jul;142(1):158-60. doi: 10.1016/j.ajo.2006.02.045. PMID 16815268

+Investigators

Mehdi Modarres, MD, Study director, Iran University of Medical Sciences(IUMS)